Bilastine Alfred E. Tiefenbacher: Uses, Dosage & Side Effects

A second-generation, non-sedating antihistamine orodispersible tablet for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria in children aged 6 to 11 years

Rx ATC: R06AX29 Second-Generation Antihistamine
Active Ingredient
Bilastine
Available Forms
Orodispersible tablet
Strength
10 mg
Manufacturer
Alfred E. Tiefenbacher

Bilastine Alfred E. Tiefenbacher is a prescription medication containing bilastine 10 mg in an orodispersible tablet formulation, specifically designed for children aged 6 to 11 years weighing at least 20 kg. Bilastine is a second-generation, non-sedating antihistamine that selectively blocks histamine H1 receptors, providing effective relief from the symptoms of allergic rhinoconjunctivitis (hay fever and perennial allergies) and urticaria (hives). The orodispersible tablet dissolves on the tongue without water, making it particularly convenient for pediatric patients. Bilastine does not significantly cross the blood-brain barrier and therefore causes minimal sedation at recommended doses, distinguishing it from older first-generation antihistamines.

Quick Facts: Bilastine Alfred E. Tiefenbacher

Active Ingredient
Bilastine
Drug Class
H1 Antihistamine
ATC Code
R06AX29
Common Uses
Allergic Rhinitis, Urticaria
Available Forms
Orodispersible Tablet
Prescription Status
Rx Only

Key Takeaways

  • Bilastine Alfred E. Tiefenbacher contains 10 mg bilastine as an orodispersible tablet designed for children aged 6 to 11 years (weighing at least 20 kg) to treat allergic rhinoconjunctivitis and urticaria.
  • As a second-generation antihistamine, bilastine provides 24-hour symptom relief with once-daily dosing and does not cause clinically significant drowsiness at the recommended dose, making it well-suited for school-age children.
  • The tablet must be taken on an empty stomach (at least 1 hour before or 2 hours after food or fruit juice) because food significantly reduces bilastine absorption by approximately 30%.
  • Bilastine has a favorable drug interaction profile because it is not significantly metabolized by cytochrome P450 enzymes; however, P-glycoprotein inhibitors (such as ketoconazole and erythromycin) may increase bilastine plasma levels.
  • Clinical trials have demonstrated bilastine has a side-effect profile comparable to placebo in children, with no clinically relevant effects on cardiac QTc interval at recommended doses.

What Is Bilastine Alfred E. Tiefenbacher and What Is It Used For?

Quick Answer: Bilastine Alfred E. Tiefenbacher is a second-generation antihistamine containing bilastine 10 mg in an orodispersible tablet. It is used to relieve symptoms of allergic rhinoconjunctivitis (sneezing, runny nose, itchy and watery eyes) and urticaria (hives with itching) in children aged 6 to 11 years weighing at least 20 kg.

Bilastine Alfred E. Tiefenbacher contains the active substance bilastine, a potent and highly selective histamine H1 receptor antagonist belonging to the second generation of antihistamines. Antihistamines work by blocking the action of histamine, a chemical messenger released by mast cells and basophils during an allergic reaction. When an allergen (such as pollen, dust mites, pet dander, or certain foods) enters the body, the immune system overreacts by producing immunoglobulin E (IgE) antibodies, which trigger the release of histamine. Histamine binds to H1 receptors in the nose, eyes, skin, and airways, causing the familiar symptoms of allergy: sneezing, nasal congestion, runny nose, itchy and watery eyes, and itchy skin rashes.

By competitively binding to H1 receptors, bilastine prevents histamine from exerting its effects on these tissues. This leads to relief from sneezing, rhinorrhea (runny nose), nasal pruritus (itching), nasal congestion, ocular itching and tearing, and cutaneous pruritus and wheals (hives). Bilastine has a rapid onset of action, with symptom relief typically beginning within approximately one hour of ingestion, and its effects last for a full 24 hours, allowing convenient once-daily dosing.

A key advantage of bilastine over first-generation antihistamines (such as diphenhydramine, chlorphenamine, and promethazine) is its minimal penetration of the blood-brain barrier. First-generation antihistamines readily enter the central nervous system and cause significant drowsiness, impaired concentration, and psychomotor dysfunction. In contrast, bilastine was specifically designed to remain predominantly outside the brain at therapeutic doses. Multiple clinical studies, including driving simulation tests and cognitive performance assessments, have confirmed that bilastine at the recommended dose does not significantly impair psychomotor function or cause sedation compared with placebo. This is particularly important for school-age children, for whom daytime alertness is essential for learning and participation in activities.

Bilastine Alfred E. Tiefenbacher is indicated for two main conditions:

  • Allergic rhinoconjunctivitis (seasonal and perennial): Seasonal allergic rhinitis (hay fever) is triggered by airborne pollen from grasses, trees, or weeds and occurs predictably during specific seasons. Perennial allergic rhinitis is caused by year-round allergens such as house dust mites, mold spores, and animal dander. Both conditions cause sneezing, runny or blocked nose, and itchy, watery eyes. Allergic rhinitis affects an estimated 10–30% of children worldwide according to WHO data, significantly impacting quality of life, sleep, and academic performance.
  • Urticaria (hives): Urticaria presents as raised, itchy, red or skin-colored wheals (welts) that may appear anywhere on the body. Chronic spontaneous urticaria can persist for weeks or months. Bilastine effectively reduces both the itching (pruritus) and the number and size of wheals. The EAACI/GA2LEN/EDF/WAO guidelines recommend second-generation H1 antihistamines as first-line therapy for urticaria.

The orodispersible tablet formulation is specifically designed for children who may have difficulty swallowing conventional tablets. The tablet is placed on the tongue, where it disintegrates rapidly and can be swallowed with saliva. No water is required, although water may be taken if desired. This formulation provides the same bioavailability as the standard bilastine tablet when taken under fasting conditions.

Non-Sedating Antihistamine

Unlike older antihistamines that commonly cause drowsiness, bilastine is classified as a non-sedating antihistamine. At the recommended dose, clinical studies have shown no significant difference in sedation rates between bilastine and placebo. This makes it especially suitable for children who need to remain alert at school and during activities. However, individual responses may vary, and parents should observe their child for any unusual drowsiness when first starting the medication.

What Should You Know Before Taking Bilastine Alfred E. Tiefenbacher?

Quick Answer: Do not give Bilastine Alfred E. Tiefenbacher if the child is allergic to bilastine or any of the other ingredients. Always administer on an empty stomach. Inform your doctor about all other medications, particularly ketoconazole, erythromycin, ciclosporin, ritonavir, or diltiazem, as these may increase bilastine levels in the blood.

Contraindications

There are specific situations in which Bilastine Alfred E. Tiefenbacher must not be used. Understanding these contraindications is essential for safe treatment.

  • Hypersensitivity: Do not use this medication if the child is allergic to bilastine or any of the excipients (inactive ingredients) in the formulation. Signs of an allergic reaction may include skin rash, swelling of the face, lips, tongue, or throat, and difficulty breathing. Seek immediate medical attention if these symptoms occur.

Warnings and Precautions

Before and during treatment with Bilastine Alfred E. Tiefenbacher, consider the following precautions and inform your doctor if any apply to the child:

  • Kidney impairment: Bilastine is excreted partly through the kidneys. Children with moderate to severe renal impairment may experience higher blood levels of bilastine. Your doctor may need to adjust the dose or choose an alternative treatment if the child has significant kidney problems.
  • Food and fruit juice interaction: Bilastine must be taken on an empty stomach. Food reduces the bioavailability of bilastine by approximately 30%, and grapefruit juice further reduces absorption. Ensure the child takes the tablet at least one hour before or two hours after meals or fruit juice. This is a critical administration requirement that directly affects the medication’s effectiveness.
  • Age and weight restrictions: This 10 mg orodispersible tablet formulation is approved for children aged 6 to 11 years weighing at least 20 kg. It is not recommended for children under 6 years due to insufficient safety and efficacy data in this age group. For adolescents aged 12 years and older and adults, the standard bilastine 20 mg tablet is typically prescribed.
  • Skin allergy testing: Bilastine may suppress the skin’s response to allergen testing (skin prick tests). If allergy testing is planned, the medication should be stopped at least three days before the tests to avoid false-negative results.
Important: Empty Stomach Administration

To ensure that bilastine is properly absorbed, the orodispersible tablet must be taken on an empty stomach – at least 1 hour before or 2 hours after eating or drinking fruit juice. Food and grapefruit juice significantly reduce the absorption of bilastine, which can make the medication less effective. Water may be consumed freely at any time.

Pregnancy and Breastfeeding

Bilastine Alfred E. Tiefenbacher 10 mg orodispersible tablets are indicated for use in children aged 6 to 11 years, and therefore pregnancy and breastfeeding are not typically relevant considerations for this specific formulation. However, for completeness of information:

There are no adequate data on the use of bilastine in pregnant women. Animal studies have not indicated direct or indirect harmful effects on reproductive toxicity at doses well above the maximum human dose. As a precautionary measure, bilastine should be avoided during pregnancy unless clearly necessary. It is not known whether bilastine is excreted in human breast milk. Animal studies have shown excretion in breast milk. A decision should be made whether to discontinue breastfeeding or to discontinue bilastine therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.

Effects on Ability to Drive and Use Machines

Studies in adults have shown that bilastine at the recommended dose has no significant effect on driving performance or the ability to operate machinery. A clinical driving study demonstrated that bilastine 20 mg (the adult dose) did not significantly impair driving performance compared with placebo, even when combined with alcohol. However, individual responses may vary. Parents should observe their child for any signs of drowsiness or reduced alertness when starting treatment, and children should be cautioned about activities requiring concentration until the individual response to the medication is known.

How Does Bilastine Alfred E. Tiefenbacher Interact with Other Drugs?

Quick Answer: Bilastine is not significantly metabolized by liver enzymes (CYP450), so it has fewer drug interactions than many other medications. However, P-glycoprotein (P-gp) inhibitors such as ketoconazole, erythromycin, ciclosporin, ritonavir, and diltiazem can increase bilastine blood levels. Food and grapefruit juice reduce absorption and should be avoided around dosing time.

One of the notable pharmacological advantages of bilastine is its minimal hepatic metabolism. Unlike many other drugs, bilastine is not significantly metabolized by cytochrome P450 (CYP) enzymes. Approximately 95% of an oral dose of bilastine is recovered unchanged, primarily in feces (approximately 67%) and urine (approximately 33%). This means that drug interactions mediated by CYP enzyme inhibition or induction are not a significant concern with bilastine. However, bilastine is a substrate of the P-glycoprotein (P-gp) efflux transporter and the organic anion transporting polypeptide 1A2 (OATP1A2), which are responsible for limiting its intestinal absorption and contributing to its elimination.

Drug interactions with bilastine are primarily related to substances that affect P-glycoprotein activity. Drugs that inhibit P-gp can increase bilastine plasma concentrations by enhancing intestinal absorption and reducing elimination. Conversely, P-gp inducers may decrease bilastine levels. Additionally, food and certain beverages (particularly grapefruit juice) affect the absorption of bilastine via OATP1A2 inhibition in the gut.

Major Interactions

Major Drug Interactions with Bilastine
Interacting Drug Effect Clinical Significance
Ketoconazole (P-gp and CYP3A4 inhibitor) Increases bilastine plasma levels approximately 2-fold Avoid concomitant use; increased risk of side effects
Erythromycin (P-gp inhibitor) Increases bilastine plasma levels approximately 2-fold Avoid concomitant use; monitor for increased side effects
Ciclosporin (P-gp inhibitor) May significantly increase bilastine plasma levels Avoid concomitant use; alternative antihistamine may be needed
Ritonavir (P-gp inhibitor) May increase bilastine absorption via P-gp inhibition Avoid concomitant use; consult physician
Grapefruit juice (OATP1A2 inhibitor) Reduces bilastine bioavailability by approximately 30% Avoid around dosing; reduces medication effectiveness

Minor Interactions

Other Drug Interactions with Bilastine
Interacting Drug Effect Clinical Significance
Diltiazem (P-gp inhibitor) May modestly increase bilastine plasma levels Use with caution; monitor for side effects
Food (general) Reduces bilastine bioavailability by approximately 30% Always administer on an empty stomach
Alcohol No significant pharmacokinetic interaction; bilastine does not potentiate alcohol-induced impairment at recommended doses Not applicable for pediatric patients; no potentiation observed in adult studies
Other antihistamines Potential for additive antihistaminic effects Avoid combining with other antihistamines unless directed by physician

It is important to note that bilastine does not inhibit CYP enzymes (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4) at concentrations achieved during therapeutic use. This means bilastine is unlikely to alter the metabolism of other drugs that are broken down by these enzymes, which is a significant pharmacological advantage in patients taking multiple medications. In clinical studies, no clinically relevant QTc prolongation was observed at doses up to 220 mg (11 times the recommended adult dose), providing reassurance about cardiac safety even in the context of accidental overdose or drug interactions.

What Is the Correct Dosage of Bilastine Alfred E. Tiefenbacher?

Quick Answer: For children aged 6 to 11 years weighing at least 20 kg, the recommended dose is one 10 mg orodispersible tablet once daily, taken on an empty stomach. For adolescents aged 12 years and older and adults, the standard bilastine dose is 20 mg once daily (different formulation). Do not exceed the recommended dose.

Bilastine Alfred E. Tiefenbacher 10 mg orodispersible tablets are specifically formulated for pediatric use. The dosing is straightforward: one tablet once daily. However, the timing of administration relative to food is critically important for ensuring proper drug absorption and effectiveness.

Children (6 to 11 Years)

Children Aged 6 to 11 Years (Weighing ≥ 20 kg)

Dose: 10 mg (one orodispersible tablet) once daily

Administration: Place the tablet on the tongue; it disintegrates rapidly and can be swallowed with saliva. No water is required.

Timing: Must be taken on an empty stomach – at least 1 hour before or 2 hours after food or fruit juice

Duration: Treatment duration depends on the type, duration, and course of the allergic condition. Your doctor will advise on how long treatment should continue.

Adolescents (12 Years and Older) and Adults

Adolescents and Adults

Dose: 20 mg bilastine once daily (standard tablet formulation, not this 10 mg orodispersible tablet)

Note: Bilastine Alfred E. Tiefenbacher 10 mg orodispersible tablets are not intended for adolescents aged 12 years and older or adults. The appropriate strength for this age group is bilastine 20 mg tablets.

Elderly Patients

This pediatric formulation is not intended for elderly patients. For elderly patients with allergic conditions, the standard bilastine 20 mg tablet is available. No dose adjustment is required for elderly patients with normal kidney function. However, elderly patients with moderate to severe renal impairment may require dose reduction or an alternative medication, and should consult their physician.

Renal and Hepatic Impairment

Bilastine is eliminated via both renal and fecal routes. In patients with renal impairment, bilastine clearance may be reduced, leading to higher plasma levels. No dose adjustment studies have been specifically conducted in pediatric patients with renal impairment. In adult studies, no dose adjustment was needed for mild renal impairment, but caution is advised for moderate to severe renal impairment. Hepatic impairment is not expected to significantly affect bilastine pharmacokinetics because bilastine undergoes minimal hepatic metabolism.

Missed Dose

If a dose is missed, the child should take the next dose at the regular scheduled time. Do not give a double dose to make up for a missed dose. Taking more than one tablet per day does not provide additional benefit and may increase the risk of side effects. If multiple doses are missed, consult the prescribing physician about whether the treatment plan should be adjusted.

Overdose

In the event of accidental overdose, seek medical advice promptly. In clinical studies involving adults, bilastine has been administered at doses up to 220 mg (11 times the recommended adult dose of 20 mg) without clinically significant adverse effects. At these suprapherapeutic doses, no clinically relevant QTc prolongation was observed. Somnolence was the most commonly reported symptom at higher doses. Treatment of overdose should be symptomatic and supportive; there is no specific antidote. As bilastine is rapidly absorbed and has a relatively long half-life (approximately 14.5 hours), gastric decontamination may be considered if the overdose is recent and the amount ingested is large.

Handling the Orodispersible Tablet

The orodispersible tablet should be removed from the blister pack with dry hands immediately before use. Place the tablet on the tongue, where it will dissolve rapidly. The child can then swallow the dissolved tablet with saliva. No water is needed, although a small sip of water is acceptable. The tablet should not be crushed, chewed, or swallowed whole with water before it has dissolved. If the tablet breaks during removal from the blister, discard it and use a new tablet.

What Are the Side Effects of Bilastine Alfred E. Tiefenbacher?

Quick Answer: Bilastine has a very favorable side-effect profile in clinical trials, with most adverse events occurring at rates similar to placebo. The most commonly reported side effects in children include headache, drowsiness, and abdominal pain. Serious side effects are very rare. Bilastine does not cause clinically significant QTc prolongation at recommended doses.

Like all medicines, bilastine can cause side effects, although not everyone gets them. Overall, bilastine has been shown to have an excellent safety and tolerability profile in both adult and pediatric clinical trials. In the pivotal clinical study of bilastine 10 mg in children aged 2 to 11 years with allergic rhinoconjunctivitis or chronic urticaria, the incidence of adverse events was comparable between bilastine and placebo groups. This means that in a clinical trial setting, children taking bilastine experienced side effects at essentially the same rate as children taking a dummy pill.

The following side effects are based on data from clinical trials and post-marketing surveillance of bilastine across all approved formulations and dose strengths:

Common

May affect up to 1 in 10 people

  • Headache
  • Drowsiness or somnolence (usually mild and transient)

Uncommon

May affect up to 1 in 100 people

  • Upper abdominal pain
  • Nausea
  • Dizziness
  • Fatigue
  • Increased appetite
  • Nasal dryness
  • Pharyngitis (sore throat)
  • Rhinitis

Rare

May affect up to 1 in 1,000 people

  • Palpitations or tachycardia (awareness of heartbeat or rapid heartbeat)
  • Anxiety or insomnia
  • Skin rash or pruritus (itching not related to the underlying allergic condition)
  • Vertigo (sensation of spinning)
  • Weight increase

Not Known

Frequency cannot be estimated from available data

  • Allergic reactions (hypersensitivity) including skin rash, urticaria, dyspnea (difficulty breathing), and anaphylaxis

Cardiac Safety

An important consideration with any antihistamine is its effect on the heart’s electrical activity, specifically the QTc interval. Some older antihistamines (notably terfenadine and astemizole, now withdrawn) were associated with dangerous cardiac arrhythmias. Bilastine has been thoroughly evaluated for cardiac safety. In a comprehensive thorough QTc study conducted according to ICH E14 guidelines, bilastine at doses up to 220 mg (11 times the recommended adult dose) did not produce clinically relevant QTc prolongation. This provides strong reassurance that bilastine has an excellent cardiac safety profile, even at suprapherapeutic doses.

Comparison with Placebo in Pediatric Trials

In the key pediatric clinical trial (a randomized, double-blind, placebo-controlled study), children aged 2 to 11 years received bilastine 10 mg or placebo once daily for 12 weeks. The overall incidence of treatment-emergent adverse events was similar in both groups. The most common adverse events in both groups were upper respiratory tract infections, headache, and pyrexia (fever), which are typical in pediatric populations regardless of treatment. There was no statistically significant difference in the rate of any individual adverse event between bilastine and placebo. Importantly, there were no serious adverse events related to bilastine treatment in this study.

When to Contact Your Doctor

While bilastine is generally well tolerated, contact your doctor or pharmacist if your child experiences any side effects that are persistent, bothersome, or concerning. Seek immediate medical attention if signs of a severe allergic reaction occur, including difficulty breathing, swelling of the face, lips, tongue, or throat, or severe skin rash with blistering. You can also report suspected side effects to your national pharmacovigilance authority.

How Should You Store Bilastine Alfred E. Tiefenbacher?

Quick Answer: Store Bilastine Alfred E. Tiefenbacher at room temperature below 30°C, in the original packaging to protect from moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the packaging.

Proper storage of medications is essential to maintain their effectiveness and safety. Bilastine Alfred E. Tiefenbacher orodispersible tablets should be stored according to the following guidelines:

  • Temperature: Store at room temperature, not exceeding 30°C (86°F). Do not refrigerate or freeze.
  • Moisture protection: Keep the tablets in the original blister packaging to protect them from moisture. Orodispersible tablets are designed to dissolve quickly when exposed to moisture, so proper packaging is important to maintain tablet integrity.
  • Light protection: No special light protection requirements, but keep in original packaging.
  • Child safety: Keep this medicine out of the sight and reach of children. Store in a safe location, as the orodispersible tablet may be mistaken for a sweet by young children.
  • Expiry date: Do not use after the expiry date stated on the blister and carton. The expiry date refers to the last day of the stated month.

Do not dispose of unused or expired tablets via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Proper disposal helps protect the environment and prevent accidental exposure.

If a tablet is damaged, broken, or discolored when removed from the blister pack, do not use it. Discard it appropriately and use a new tablet from an intact blister.

What Does Bilastine Alfred E. Tiefenbacher Contain?

Quick Answer: Each orodispersible tablet contains 10 mg of bilastine as the active substance. The inactive ingredients include excipients commonly used in orodispersible tablet formulations to ensure rapid disintegration on the tongue.

Active Substance

The active substance is bilastine. Each orodispersible tablet contains 10 mg of bilastine. Bilastine is a selective histamine H1 receptor antagonist with the chemical name 2-[4-(2-(4-(1-(2-ethoxyethyl)-1H-benzimidazol-2-yl)piperidin-1-yl)ethyl)phenyl]-2-methylpropionic acid. It has a molecular formula of C28H37N3O3 and a molecular weight of approximately 463.6 g/mol. Bilastine is a white to off-white crystalline powder that is practically insoluble in water.

Inactive Ingredients (Excipients)

The orodispersible tablet formulation contains excipients selected to ensure rapid disintegration on the tongue, pleasant taste (important for pediatric acceptance), and adequate stability. Typical excipients in bilastine orodispersible tablets may include:

  • Mannitol (sweetening agent and filler)
  • Crospovidone (disintegrant to enable rapid tablet dissolution)
  • Povidone (binder)
  • Magnesium stearate (lubricant)
  • Colloidal silicon dioxide (flow agent)
  • Flavoring agents (to improve palatability for children)

The exact composition may vary between manufacturing batches and market presentations. Please refer to the patient information leaflet included with your specific package for the complete list of excipients. If you know that your child is allergic or sensitive to any of these ingredients, inform your doctor or pharmacist before starting treatment.

Appearance

Bilastine Alfred E. Tiefenbacher 10 mg orodispersible tablets are white to off-white, round tablets. They are packaged in aluminum/aluminum blister packs to protect from moisture. Each blister strip contains a defined number of tablets, and the packaging includes a patient information leaflet with full prescribing details.

Manufacturer

Bilastine Alfred E. Tiefenbacher is manufactured by Alfred E. Tiefenbacher (GmbH & Co. KG), a pharmaceutical company based in Germany. Alfred E. Tiefenbacher is an established manufacturer of generic and branded pharmaceutical products, operating under Good Manufacturing Practice (GMP) standards as required by European regulatory authorities. The product is distributed in various markets under applicable regulatory approvals.

Frequently Asked Questions About Bilastine Alfred E. Tiefenbacher

Bilastine Alfred E. Tiefenbacher is a second-generation antihistamine used to relieve symptoms of allergic rhinoconjunctivitis (seasonal and perennial hay fever, including sneezing, runny nose, itchy and watery eyes) and urticaria (hives with itching) in children aged 6 to 11 years weighing at least 20 kg. It works by blocking histamine H1 receptors to reduce the body’s allergic response.

Remove the tablet from the blister with dry hands and place it on the tongue. The tablet will dissolve rapidly and can be swallowed with saliva – no water is needed. It must be taken on an empty stomach, at least 1 hour before or 2 hours after food or fruit juice. Water can be consumed at any time. The recommended dose for children aged 6 to 11 years is one 10 mg tablet once daily.

Bilastine is classified as a non-sedating antihistamine. In clinical trials involving children, the rate of drowsiness was similar to placebo. Unlike first-generation antihistamines (such as diphenhydramine or chlorphenamine), bilastine does not significantly cross the blood-brain barrier at recommended doses, resulting in minimal sedation. However, individual responses may vary, and parents should observe their child for any unusual drowsiness, particularly when starting treatment.

Food and fruit juice significantly reduce the absorption of bilastine in the gastrointestinal tract. Studies have shown that food decreases bilastine bioavailability by approximately 30%, and grapefruit juice has a similar effect through inhibition of OATP1A2 transporters. This means the body absorbs less of the medication when taken with food, potentially reducing its effectiveness. By taking bilastine on an empty stomach, you ensure optimal absorption and the best therapeutic effect.

Bilastine Alfred E. Tiefenbacher 10 mg orodispersible tablets are approved for children aged 6 to 11 years weighing at least 20 kg. For children under 6 years of age, there is insufficient safety and efficacy data to recommend bilastine. Your doctor may recommend alternative antihistamine treatments that have been studied and approved for younger children, such as cetirizine or desloratadine, which are available in syrup formulations suitable for younger pediatric patients.

All three are second-generation antihistamines, but they have some differences. Bilastine is considered truly non-sedating at recommended doses, whereas cetirizine has a slightly higher incidence of somnolence. Loratadine is also largely non-sedating. A key difference is that bilastine is not metabolized by CYP enzymes, which means it has fewer potential drug interactions than loratadine (which is metabolized by CYP3A4 and CYP2D6). However, bilastine must be taken on an empty stomach, which is not required for cetirizine or loratadine. Your doctor will recommend the most appropriate antihistamine based on your child’s individual needs.

References

  1. European Medicines Agency (EMA). Bilastine – Summary of Product Characteristics (SmPC). Available from: EMA.
  2. Brózek JL, Bousquet J, Agache I, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines – 2023 revision. J Allergy Clin Immunol. 2023;152(4):846–863. doi:10.1016/j.jaci.2023.06.001.
  3. Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022;77(3):734–766. doi:10.1111/all.15090.
  4. Jauregui I, Bartra J, del Cuvillo A, et al. Bilastine and quality of life in allergic rhinoconjunctivitis and urticaria. J Investig Allergol Clin Immunol. 2020;30(Suppl 1):S2–S12.
  5. Sologuren A, Lucero ML, Valiente R, et al. Bilastine pharmacokinetics in children aged 2 to <12 years: a randomized, double-blind, placebo-controlled study. Clin Drug Investig. 2019;39(11):1085–1094. doi:10.1007/s40261-019-00834-y.
  6. Corcostegui R, Labeaga L, Innerarity A, et al. Preclinical pharmacology of bilastine, a new selective histamine H1 receptor antagonist. Drugs RD. 2005;6(6):371–384. doi:10.2165/00126839-200506060-00005.
  7. Graff C, Struijk JJ, Kanters JK, Andersen MP, Toft E, Tyl B. Bilastine effects on cardiac repolarization: a thorough QTc study. J Clin Pharmacol. 2012;52(9):1405–1417. doi:10.1177/0091270011419853.
  8. García-Gea C, Martínez-Colubi M, Antonijoan RM, et al. Effects of bilastine on driving and the combination of bilastine and alcohol on driving performance at highway and city traffic speed in healthy volunteers. Fundam Clin Pharmacol. 2014;28(5):557–565. doi:10.1111/fcp.12067.
  9. World Health Organization (WHO). Allergic Rhinitis and Allergic Diseases: Global Epidemiology and Burden. Geneva: WHO; 2023.
  10. British National Formulary for Children (BNFC). Bilastine. National Institute for Health and Care Excellence (NICE). Available from: BNFC.

Editorial Team

This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in allergy, immunology, pediatrics, and clinical pharmacology.

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